stool softener

Drug Facts

Composition & Product

Active Ingredients

docusate (100 mg)

Inactive Ingredients

anhydrous citric acid fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol, unspecified propylene glycol water sorbitol sorbitan

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2018-03-29

Medication Information

Uses

for relief of occasional constipation (irregularity)
this product generally produces a bowel movement in 12 to 72 hours

Purpose

Stool softener laxative

Directions

take softgels with a full glass (8oz) of water

adults and children 12 years and older	take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
children 6 to under 12 years	take 1 softgel daily or as directed by a doctor
children under 6 years	ask a doctor

Other Information

each softgel contains: sodium 5 mg
store at room temperature 15°-30°C (59°-86°F)
protect from excessive humidity

Inactive Ingredients

anhydrous citric acid, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Description

Drug Facts

Principal Display Panel

Stool Softener

DOCUSATE SODIUM 100 mg 30 SOFTGELS

Compare to Phillips' Stool Softener Liquid Gels active ingredient

NDC 51013-433-20

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50568-5

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Questions Or Comments?

Call toll free: 1-855-215-8180

Stop Use and Ask A Doctor If

you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have

stomach pain, nausea, or vomiting
a sudden change in bowel habits that lasts over 14 days

Structured Label Content

Uses

for relief of occasional constipation (irregularity)
this product generally produces a bowel movement in 12 to 72 hours

Purpose

Stool softener laxative

Directions

take softgels with a full glass (8oz) of water

adults and children 12 years and older	take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
children 6 to under 12 years	take 1 softgel daily or as directed by a doctor
children under 6 years	ask a doctor

Other Information (Other information)

each softgel contains: sodium 5 mg
store at room temperature 15°-30°C (59°-86°F)
protect from excessive humidity

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stool Softener

DOCUSATE SODIUM 100 mg 30 SOFTGELS

Compare to Phillips' Stool Softener Liquid Gels active ingredient

NDC 51013-433-20

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Questions Or Comments? (Questions or comments?)

Call toll free: 1-855-215-8180

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

stomach pain, nausea, or vomiting
a sudden change in bowel habits that lasts over 14 days

Advanced Ingredient Data

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional constipation (irregularity) this product generally produces a bowel movement in 12 to 72 hours", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.", "50568-5": "Ask a doctor or pharmacist before use if you are presently taking mineral oil", "53414-9": "If pregnant or breast-feeding, ask a health professional before use", "Purpose": "Stool softener laxative", "Directions": "take softgels with a full glass (8oz) of water adults and children 12 years and older take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses. children 6 to under 12 years take 1 softgel daily or as directed by a doctor children under 6 years ask a doctor", "Other information": "each softgel contains: sodium 5 mg store at room temperature 15°-30°C (59°-86°F) protect from excessive humidity", "Inactive ingredients": "anhydrous citric acid, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink", "Questions or comments?": "Call toll free: 1-855-215-8180", "PRINCIPAL DISPLAY PANEL": "Stool Softener DOCUSATE SODIUM 100 mg 30 SOFTGELS Compare to Phillips' Stool Softener Liquid Gels active ingredient NDC 51013-433-20", "Stop use and ask a doctor if": "you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week", "Active ingredient (in each softgel)": "Docusate sodium 100 mg", "Ask a doctor before use if you have": "stomach pain, nausea, or vomiting a sudden change in bowel habits that lasts over 14 days"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information